Alzheimer's DiseaseCREDOSNCT01198093
Clinical Research Center for Dementia of South Korea (CREDOS)(or CRCD)
An observational study of Alzheimer's Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The objective of this study is to present evidence-based medicine for development of clinical practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive impairment(MCI) in korea Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2005to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. Patient populatin who is suffering from memory impairment 2. Normal subjects matched with age and gender
Who may be able to join
- Alzheimer's disease(AD) and mild cognitive impairment(MCI)will be enrolled in the study.
- the diagnostic criteria of Alzheimer's disease(AD) according to DSM IV or NINCDS -ADRDA
- the diagnostic criteria of mild cognitive impairment(MCI) A. Memory or other cognitive complaint preferably corroborated by an informant B. Objective memory impairment or other cognitive for age and education C. Largely intact general cognitive function D. Essentially preserved ADL E. Not demented
Who cannot join
- Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Kangnam-Ku, 135-710
Doh Kwan Kim, M.D and Ph.D, 82-2-3410-3582, paulkim@skku.edu
About this study
Official title: Clinical Research Center for Dementia of South Korea (CREDOS)
The objective of this study is to present evidence-based medicine for development of clinical practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive impairment(MCI) in korea
Read the detailed description
The specific aims of this study is (1) construction \& maintenance of cohort for Alzheimer's disease(AD) and mild cognitive impairment(MCI); (2) study of epidemiology, rate of progression, risk factor, prognostic factor; (3) study of biomarker such as neuropsychological assessment, peripheral \& CSF markers, neuroimaging(both structural \& functional)
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, cohort study
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startNov 2005
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Doh Kwan Kim, Samsung Medical Center
- Investigators
- Doh K KIm, Ph.D, Principal investigator, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198093
- Sponsor's protocol ID
- 2005-02-008
- Acronym
- CREDOS
- Status last verified
- Sep 2012
- First submitted
- 8 Sep 2010
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee YM, Park JM, Lee BD, Moon E, Jeong HJ, Chung YI, Kim JH, Kim HJ, Mun CW, Kim TH, Kim YH. Gray matter volumes and treatment response of psychotic symptoms to risperidone in antipsychotic-naive Alzheimer's disease patients. J Clin Psychiatry. 2016 Jan;77(1):e8-13. doi: 10.4088/JCP.14m09740.
PubMed 26845282Yoon B, Shim YS, Cheong HK, Hong YJ, Lee KS, Park KH, Ahn KJ, Kim DJ, Kim YD, Choi SH, Yang DW. White matter hyperintensities in mild cognitive impairment: clinical impact of location and interaction with lacunes and medial temporal atrophy. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):e365-72. doi: 10.1016/j.jstrokecerebrovasdis.2013.12.040. Epub 2014 Feb 28.
PubMed 24589036
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Center for Dementia of South Korea (CREDOS)
- ClinicalTrials.gov ID
- NCT01198093
- Acronym / sponsor ID
- CREDOS / 2005-02-008
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Nov 2005
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to present evidence-based medicine for development of clinical practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive impairment(MCI) in korea
Detailed description
The specific aims of this study is (1) construction \& maintenance of cohort for Alzheimer's disease(AD) and mild cognitive impairment(MCI); (2) study of epidemiology, rate of progression, risk factor, prognostic factor; (3) study of biomarker such as neuropsychological assessment, peripheral \& CSF markers, neuroimaging(both structural \& functional)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Patient populatin who is suffering from memory impairment 2. Normal subjects matched with age and gender
Key inclusion criteria (3 listed)
- Alzheimer's disease(AD) and mild cognitive impairment(MCI)will be enrolled in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Derived from this study: PubMed 26845282Lee YM, Park JM, Lee BD, Moon E, Jeong HJ, Chung YI, Kim JH, Kim HJ, Mun CW, Kim TH, Kim YH. Gray matter volumes and treatment response of psychotic symptoms to risperidone in antipsychotic-naive Alzheimer's disease patients. J Clin Psychiatry. 2016 Jan;77(1):e8-13. doi: 10.4088/JCP.14m09740.
- Derived from this study: PubMed 24589036Yoon B, Shim YS, Cheong HK, Hong YJ, Lee KS, Park KH, Ahn KJ, Kim DJ, Kim YD, Choi SH, Yang DW. White matter hyperintensities in mild cognitive impairment: clinical impact of location and interaction with lacunes and medial temporal atrophy. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):e365-72. doi: 10.1016/j.jstrokecerebrovasdis.2013.12.040. Epub 2014 Feb 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doh K KIm, Ph.D principal investigator
Ministry of Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doh K Kim, Ph.D (82-2-3410-3582, dohkwan.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01198093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2012.